HHS launches AI-driven program to accelerate clinical trials with $100M in funding

The Health and Human Services Department announced a program and three projects under its Advanced Research Projects Agency for Health, or ARPA-H, to speed up clinical trials using artificial intelligence, advanced computational models, and real-time analysis. The SURPASS program will create AI-powered platforms that continuously and adaptively support clinical trial designs, enabling earlier and smarter decision-making to help speed effective drugs to patients, according to an HHS press release.

Companies participating in the SURPASS program must focus on three technical areas: building a phaseless design engine to simulate clinical trials for faster, regulation-compliant trials with fewer patients; developing a continuous inference engine for real-time or on-demand analysis of clinical trial data to support trial adaptations; and creating an agentic AI operations layer to automate trial startup activities, speed up data collection, and support other procedures.

HHS also unveiled three complementary ARPA-H initiatives: STACK, COMMONS, and CINCH. STACK aims to accelerate clinical site activation and convert research-naïve sites into clinical trial sites using AI, with Evidence Health as the prime awardee and potential funding of up to $41.18 million. COMMONS will build nationwide data infrastructure, including architecture for consent at national scale and access to regulatory-grade data, targeting over 40 million individuals and 3 million linked records, with Evidence Health as the prime awardee and potential funding of up to $49.9 million.

The CINCH initiative will help cancer patients contribute their own data to speed up the identification of appropriate clinical trials, operating as a patient-initiated way for adults to better understand their conditions. Courage Health is the prime CINCH awardee with potential funding of up to $8.95 million.

The HHS initiatives build on prior efforts, including Operation TrialBlazer, a department-wide effort launched in June to support clinical trials through pilot programs, public-private partnerships, and patient connections. The Food and Drug Administration also announced in April a pilot program using AI and cloud computing to monitor clinical trial data in real time, with an FDA official estimating it could cut overall clinical trial times by as much as 40% without compromising patient safety.

HHS noted that the clinical development of drugs and biologics often takes over a decade, costs an average of up to $2 billion, and fails more than 90% of the time.